The effect of supplementation using both protein and multiple micronutrients in preschool age children on cognitive performance and growth is unknown. The study will compare the effect of combination of protein and multiple micronutrients on indicators of cognitive performance and growth in preschool age children. Cognitive performance and anthropometric assessments will be measured at baseline and at 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
528
High protein and added Micronutrients at recommended dietary allowance levels
Low protein and no added micronutrients
GSK Investigational Site
Karamsad, Gujarat, India
Change From Baseline in Short Term Memory at 6 Months
Short term memory was measured using word order and number recall sub tests of Kaufman Assessment Battery for Children (KABC).In Number Recall, child was asked to repeat series of number in same sequence after making sure that child is paying attention.A score of 0 and 1 given for incorrect and correct response respectively. In Word Order,qualified site staff said series of words and child then pointed pictures of those words in same sequence.Later items (object cards with pictures) included an interference task in which child named colors after hearing the word. Each subtest score was the total of item scores, ranging from 0-31 for word order and 0-22 for number recall. The two subtest scores were standardized for each subject and visit (Z score), and short term memory was calculated as the average of the two standardized values where higher scores reflect better short term memory.
Time frame: Baseline and 6 months
Change From Baseline in Weight at 6 Months
Weight was measured (single measurement) in standard clothing on weighing scale to the nearest 0.1kilograms(kg).
Time frame: Baseline and 6 months
Change From Baseline in Height at 6 Months
Height was measured (single measurement) using a portable stadio-meter, with the participant standing bare-foot, to the nearest 0.1centimeters (cm).
Time frame: Baseline and 6 months
Change From Baseline in Body Mass Index (BMI) at 6 Months
BMI for was obtained using the World Health Organization Anthroplus software version 1.0.2.
Time frame: Baseline and 6 months
Change From Baseline in Triceps Skin Fold (TSF) at 6 Months
The TSF was measured in the midline of the posterior aspect of the arm, over the triceps muscle, at a level midway between the lateral projection of the acromion process of the scapula and the inferior margin of the olecranon process of the ulna. The right elbow is flexed at 90°and the midpoint between the acromion and the olecranon process is located and marked at the lateral side of the arm. The skinfold was then measured with the arm hanging loosely while standing. The triceps skinfold was picked up with the left thumb and index finger approximately 1cm proximal to the marked level and the tips calipers were applied to the skin-fold at the marked level. The triceps measurement was done (three measurements) using Holtain calipers to the nearest 0.2 millimeters (mm) and the average value was recorded.
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Time frame: Baseline and 6 months
Change From Baseline in Mid Upper Arm Circumference (MUAC) at 6 Months
The MUAC (single measurement) was measured midway between the acromion and the olecranon process, while the participant stands with the elbow flexed at 90. The circumference was measured with a fiber glass tape to the nearest 0.1 cm on the right hand.
Time frame: Baseline and 6 months
Change From Baseline in Arm Muscle Area (AMA) and Arm Fat Area (AFA) at 6 Months
Using the MUAC measurement and TSF measurement, the arm muscle AMA and AFA were calculated i.e. AMA (cm2) = (MUAC-(π\*TSF))2/4 π and AFA (cm2) = (MUAC2/4π) - AMA
Time frame: Baseline and 6 months
Number of Ill Days at 6 Months
Number of ill days due to cold, cough and/or associated fever were recorded. The mean number of ill days due was analyzed at 6 months using Analysis of Variance (ANOVA).
Time frame: Baseline upto 6 months
Change From Baseline in Problem Solving at 6 Months
Test measured visual construction ability, understanding of spatial relationships and problem solving abilities. The child arranged flat shapes of various sizes and colors (items) to match a model or picture as instructed by the qualified staff. For items 1 to 2 (score 2 for success on first trial and 1 on second trial); items 3 to 10 (Score 1 for success and 0 for failure on first trial). The test continued till 3 consecutive scores of 0. The Raw score was the total of item score. Score range 0-29. Higher scores reflect better short term memory
Time frame: Baseline and 6 months